DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C

System, Imaging, Pulsed Doppler, Ultrasonic

SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI

The following data is part of a premarket notification filed by Shantou I Nstitute Of Ultrasonic Instruments (siui with the FDA for Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array Transducer, Model C3l60c.

Pre-market Notification Details

• Device ID: K102023
• 510k Number: K102023
• Device Name: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE Dublin, CA 94568
• Contact: Bob Leiker
• Correspondent: Bob Leiker; SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI 7263 CRONIN CIRCLE Dublin, CA 94568
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-19
• Decision Date: 2010-10-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06938396435004	K102023	000
06938396433000	K102023	000